Evaluation of Myocardial Reperfusion After Primary PCI in Patients With High Platelet Reactivity Treated by Cangrelor or Not

NCT ID: NCT04927949

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2023-03-31

Brief Summary

This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor -a potent and immediate P2Y12 inhibitor- to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.

Detailed Description

Despite the use of potent P2Y12 inhibitor such as ticagrelor, half of the patients presented high platelet reactivity (HPR) at the time of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). HPR has been associated with impaired myocardial reperfusion. Myocardial reperfusion, assessed using myocardial blush grade, is a strong prognostic factor associated with infarct size and mortality. Antiplatelet therapy intensification using a potent and immediate P2Y12 inhibitor such as Cangrelor according a point-of-care platelet function test has not been studied in the acute phase of STEMI.

This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.

Conditions

ST-elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients without HPR

standard primary PCI

Group Type: SHAM_COMPARATOR

standard PCI

Intervention Type: PROCEDURE

primary PCI without cangrelor

patients with HPR randomized to cangrelor

Cangrelor perfusion started before PCI

Group Type: EXPERIMENTAL

cangrelor perfusion during PCI

Intervention Type: DRUG

Cangrelor perfusion (started before PCI) with intravenous bolus of 30 microgram/kg, followed by a perfusion of 4 microgram/kg/min during 2 hours or until the end of the PCI if longer

patients with HPR randomized to standard of care

standard primary PCI

Group Type: PLACEBO_COMPARATOR

standard PCI

Intervention Type: PROCEDURE

primary PCI without cangrelor

Interventions

cangrelor perfusion during PCI

Cangrelor perfusion (started before PCI) with intravenous bolus of 30 microgram/kg, followed by a perfusion of 4 microgram/kg/min during 2 hours or until the end of the PCI if longer

Intervention Type: DRUG

standard PCI

primary PCI without cangrelor

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patient admitted for STEMI within 24 hours from symptom onset
• pretreated with ticagrelor, aspirin and enoxaparin (according local protocol)
• successfully treated by primary PCI of a native coronary culprit lesion
• anatomy accessible to optical coherence tomography (OCT or OFDI)

Exclusion Criteria

• cardiogenic shock
• stent restenosis or thrombosis
• use of glycoprotein IIb/IIIa inhibitors before or during PCI
• known coagulation disease
• high bleeding risk (thrombocytopenia <100,000/dL, surgery <30 days, active bleeding)
• uncontrolled arterial hypertension (>180/110 mmHg)
• history of stroke (ischemic or hemorrhagic) or transient ischemic attack
• known severe renal insufficiency (eGFR <30 ml/min)
• oral anticoagulation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Medical Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CAEN University Hospital

Caen, , France

Countries

France

Other Identifiers

20-126

Identifier Type: -

Identifier Source: org_study_id